S02 ISS.docx

Special Notice

Special Notice

NOTICE OF INTENT TO SOLE SOURCE

Scrambler Device

The Department of Veterans Affairs Cleveland Veterans Affairs Medical Center (CLE VAMC), 10701 East Blvd., Cleveland, OH 44106 intends to solicit and negotiate with only one source under the authority of RFO - Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. The NAICS code is 334519 with a small business size standard of 1,250 employees. The VA intends to solicit and negotiate with Delta International Services & Logistics, Inc. dba Erickson Strong Medical, 506 Honea Egypt Road, #960, Magnolia, Texas, 77354-2566, for a scrambler therapy device.

The Scrambler Therapy ST-5A Technology Medical Device is a medical device used for non-invasive pain management, designed to provide therapy for patients with chronic or neuropathic pain. The requirement is for a fully manufactured, ready-to-use device that meets Cleveland VA Medical Center (CLE VAMC) specifications. The device must be sourced from an authorized distributor to ensure quality and manufacturer support. Erickson Strong Medical, a verified small business, is the exclusive distributor for this device, and it is manufactured in Italy, requiring a Buy American Act waiver for procurement.

The Scrambler Therapy ST-5A is a patented, proprietary pain management technology that differs significantly from conventional electrical stimulation devices. Unlike TENS units, which rely on the gate-control theory of pain blocking, the Scrambler Therapy system employs Shannon information theory to deliver variable, non-repetitive synthetic signals that remodel pain perception at the central nervous system level.

The system is manufactured exclusively by Delta International Services & Logistics, Inc. dba Erickson Strong Medical in Italy and distributed solely in the United States by Delta International Services & Logistics, Inc. dba Erickson Strong Medical, located in Magnolia, Texas. There are no American-made equivalents to the Scrambler Therapy ST-5A system .

The device has been clinically validated in independent studies conducted by the Mayo Clinic, Johns Hopkins University, and MD Anderson Cancer Center, with reported 80–90% effectiveness and no significant adverse effects. These features—algorithmic signal variation, non-opioid therapy modality, and independently verified clinical efficacy—are unique to the Scrambler Therapy ST-5A system and are not replicated by any other device on the market.

Other persons may identify their interest and capability to respond to this requirement by Monday, February 2, 2026, at 5PM EST. Such capabilities information will be used solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. All information shall be furnished at no cost or obligation to the Government. A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. No solicitation is available at this time. All inquiries must be submitted by email to Rachelle Hamer at rachelle.hamer@va.gov.

Enter “RFQ 36C25026Q0259 | Scrambler Device” in the email subject line.

Special Notice